Events

Rappel de Device Recall Travel Kit

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Madison Polymeric Engineering.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    79826
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1899-2018
  • Date de mise en oeuvre de l'événement
    2018-03-21
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163613
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Accessories, cleaning brushes, for endoscope - Product Code MNL
  • Cause
    The products exhibit an unpleasant odor due to microbial contamination with yarrowia lipolytica.
  • Action
    Notification letters were distributed on 3/21/18. The letters instructed customers to perform the following: 1. Immediately quarantine, and discontinue the use or distribution of First Step EP-3, EP-4, EP-6, 4" Button Brush EP-4B; Travel Kit TK200(W); and Draco Enzymatic Deep-Cleaning Pad HY0305Z with the referenced lot numbers specified in Table1. 2. Determine if any stock of the with the reference lot numbers specified in Table 1 remains in your inventory. We ask that you discard the product at your facility and document the quantity discarded on the form. Otherwise, we can issue you a Return Goods Authorization, call tag and/or Fed EX/UPS account number to have the product returned back to us. 3. Please complete the attached form and return to Cygnus Medical as indicated as soon as possible. It is important to notify Cygnus Medical whether or not your facility has any inventory of this product. 4. Please notify any of your customers who may have received lots with the referenced lot numbers specified in Table 1 with the letter provided. Your assistance is appreciated and necessary.

Device

Device Recall Travel Kit
  • Modèle / numéro de série
    Lot Numbers: EX20190103P, EX20190105P, EX20190111P, EX20190112P, EX20181220P, EX20181227P, EX20181228P, EX20181229P
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed in Canada.
  • Description du dispositif
    Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W)
  • Manufacturer
    Madison Polymeric Engineering

Manufacturer

Madison Polymeric Engineering